(78 days)
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No
The document describes standard examination gloves and their physical properties and performance against ASTM standards and FDA requirements. There is no mention of AI or ML.
No.
The device is described as a "patient examination glove" intended to prevent contamination between the patient and examiner, and its function is to be worn on the hand or fingers. It does not actively treat or alleviate a medical condition, disease, or injury.
No
The device, an examination glove, is intended for preventing contamination between a patient and examiner, not for diagnosis.
No
The device is a physical examination glove made of polybutadiene copolymer, not software. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Intended Use: The intended use of this device is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This is a barrier device used for infection control during physical examinations.
- Lack of Diagnostic Function: The description and performance data focus on the physical properties and barrier function of the glove (watertightness, strength, thickness, biocompatibility). There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the provided information, this patient examination glove is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
80LZA
Device Description
Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or fingers
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves based on ASTM D6319-00a" and FDA 1000ML watertight test.
Key results included:
- Watertight (1000ml) - Pass GI AQL = 2.5
- Length (mm): 240 mm minimum for all sizes (XS, S, M, L, XL)
- Palm width (mm): XS: 73 - 78, S: 83 - 88, M: 93 - 98, L: 103 - 107
- Thickness (mm) (Single Layer): Finger Min 0.08, Palm Min 0.08
- Physical Properties Before Aging: Tensile Strength (MPa) 17-21, Ultimate Elongation (%) 630 - 710
- Physical Properties After Aging: Tensile Strength (MPa) 16-20, Ultimate Elongation (%) 610-670
- Powder Content: Below 2 mg/glove
The performance data of the glove meets the ASTM D6319-00a83 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image shows a black abstract symbol. The symbol is composed of geometric shapes, including a curved line at the top and several rectangular shapes below. The overall design appears symmetrical and stylized.
YTY INDUSTRY (MANJUNG) SDN. BHD.
(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia, Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
- MAR 2 2004
1.0
2.0
APPENDIX-J SMDA 510 (K) SUMMARY YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir 32020 Sitiawan Perak Darul Ridzuan MALAYSIA 605-6792288 605-6791188
- MR. MOH UNG NANG Name of Contact Person
Official Correspondence 2. MS. JANNA TUCKER
Date of Summary Prepared
3.0 Name of Device
Submitter
Tel
Fax
| Trade Name: | Non-Sterile Blue & White Colour Powder Free Barrier Pro™
Polybutadiene Copolymer Examination Gloves |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Synthetic Rubber Examination Gloves |
| Classification Name: | Patient Examination Glove, Powder Free |
October 30, 2003
Identification of The Legally Marketed Devices 4.0
Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-00a63, Standard Specification for Nitrile Gloves for Medical Application.
5.0 Description of The Device
Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.
1
The Intended Use of Glove 6.0
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Summary of Performance Data: 7.0
Performance data of gloves based on ASTM D6319-00a" and FDA 1000ML watertight test.
| TEST | ASTM D6319-00a3 | POWDER FREE BARRIER
PROTM EXAM. GLOVES |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------|
| 1. Watertight (1000ml) | Multiple Normal
GI AQL = 2.5 | Pass GI AQL = 2.5 |
| 2. Length (mm)
Size
XS
S
M
L
XL | Min 220
Min 220
Min 230
Min 230
-
| 240 mm minimum for all sizes |
| 3. Palm width (mm)
Size
XS
S
M
L
XL | $70 \pm 10$
$80 \pm 10$
$95 \pm 10$
$111 \pm 10$
- | 73 - 78
83 - 88
93 - 98
103 - 107 |
| 4. Thickness (mm)
(Single Layer)
Finger
Palm | Min 0.05
Min 0.05 | Min 0.08
Min 0.08 |
| 5. Physical Properties
Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%)
After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500
Min 14
Min 400 | 17-21
630 - 710
16-20
610-670 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
2
K03-3887
- The performance data of the glove as shown above meet the ASTM D6319-00a83 8.0 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Glove meets:
- ASTM D6319-00a63 Standard -
- -FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAR - 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
YTY Industry (Manjung) SDN. BHD. Ms. Janna P. Tucker Official Correspondents Tucker & Assoclates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K033887
Trade/Device Name: Non-Sterile, Blue & White Colour Powder Free Barrier ProTM Polybutadiene Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2003 Received: December 15, 2003
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph. D.
Chiu Lin, Ph., Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ... ...... K033887
Non-Sterile, Blue & White Colour Powder Free Barrier Pro™ Device Name: Polybutadiene Copolymer Examination Gloves
Indications For Use:
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Ques
(Division Sr. Off) Division a thesiology, General Hospital, Infection Control, Dental De
510(k) Number: K033887
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)